The primary objective is to assess antibody responses against the SARS-CoV-2 vaccines in blood of individuals of 52-90 years of age at several timepoints post vaccination and post booster vaccinations, with respect to age, co-morbidities and frailty…
Source
Brief title
Condition
- Other condition
- Viral infectious disorders
Synonym
Health condition
immuunsysteem
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month
till 12 months following the second SARS-CoV-2 vaccination and post booster
vaccinations. Vaccine responses will be related to age, sex, co-morbidities and
frailty characteristics.
Secondary outcome
Vaccine-specific (Spike-protein-specific) antibody levels in serum at 1 month
after the first SARS-CoV-2 vaccination. In addition, the possible interference
of infection with SARS-CoV-2 in vaccine responsiveness will be determined by
measuring serum antibodies to SARS-CoV-2 virus core protein N.
Exploratory endpoints: Cellular and serological biomarkers before vaccination
will be identified and related to antibody responses to vaccination.
Potentially, differences between vaccines might be assessed depending on the
vaccines to be used in this age group of study participants in Doetinchem. In
addition, antibody responses to SARS-CoV-2 vaccination in a frail sub cohort of
older persons living in nursing homes will be determined from 6 months onwards
after the last vaccination and related to those of age-matched persons in the
DCS.
Background summary
Vaccination against SARS-CoV-2 is the most effective way to end the current
pandemic, although systemic immune responses induced by the various vaccines
may vary considerably in amplitude, longevity and quality per person. In
addition, with ageing there is a decline in the functioning of the immune
system, making older people more vulnerable to infections and prone to lower
responses to vaccination. Since there is great heterogeneity in the rate at
which immune function declines, it is important to identify elderly at risk for
potential low vaccination responses and thus at higher risk for infection. We
will assess the induction of antibody responses to vaccination in older and
middle-aged men and women of 52-90 years of age. In addition we will
investigate whether age, co-morbidities, frailty or underlying lingering
inflammation in these individuals might underly lower responses to the
SARS-CoV-2 vaccines.
To study this, we will capitalize on the infrastructure and data provided by
the ongoing longitudinal Doetinchem Cohort Study (DCS) (NL63779.041.17), which
includes available data on lifestyle, metabolic factors, co-morbidities and
frailty of all participants. In the DCS, persons originally 20-59 years of age
at study start, have been followed for over 30 years (N>3700). Various frailty
parameters have been assessed in these participants. Based on these, a frailty
score (index) has been determined by using the most recent information on 36
frailty-related *health deficits*, i.e. specific (co)morbidities, tests of
physical (dys)functioning and cognition. Because of these data the DCS provides
a unique opportunity to get insight into factors affecting vaccine
immunogenicity in older and middle-aged persons. Recent data from a sub-cohort
of the DCS aged 60-80 years revealed that lingering inflammation is associated
with frailty. Therefore, frailty may be linked to reduced immune function and
vaccination responses.
Study objective
The primary objective is to assess antibody responses against the SARS-CoV-2
vaccines in blood of individuals of 52-90 years of age at several timepoints
post vaccination and post booster vaccinations, with respect to age,
co-morbidities and frailty, taking sex differences into account. The secondary
aim is to address which specific pre-vaccination frailty characteristics and
metabolic and immunological biomarkers are related to low or high vaccination
responses using state of the art statistical analyses. Altogether, being able
to identify frailty or unfavorable 'biological ageing' may be useful in
conceiving individualized approaches for improved vaccination strategies or
alternative interventions to better protect older persons against SARS-CoV-2
disease.
Study design
Longitudinal observational study
Study burden and risks
The burden associated with participation involves collection of blood samples
by fingerpricks performed by the participant at home. In addition, the subject
will be asked to fill in brief questionnaires. The potential risks of the
fingerprick are considered minimal. The results of the study may contribute to
a better control of SARS-CoV-2 disease in older and middle aged persons.
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721 MA
NL
Listed location countries
Age
Inclusion criteria
• Having participated in round 6 of the Doetinchem Cohort study or living in a
nursing home
• Willing to receive the SARS-CoV-2 vaccine or received the vaccination not
longer than 1 month in advance for the DC participants or not longer than 7
months ago for nursing home residents.
• Willing to sign the Informed Consent.
Exclusion criteria
* DCS Participant already received his second SARS-CoV-2 vaccination more than
1 month before signing the ICF, so sampling at T2 and further is not possible.
* participants living in a nursing home already received both primary
SARS-CoV-2 vaccinations
more than 7 months before signing ICF.
* Incapacitated participants
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
EudraCT | EUCTR2021-001976-40-NL |
CCMO | NL76551.041.21 |